FDA Inspection
Conceptions FloridaConceptions Florida – FDA Inspection, Nov 17, 2015
Record Details
This FDA Inspection record concerns Conceptions Florida, with an inspection on November 17, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Conceptions Florida
- Inspection Date
- November 17, 2015
- Product Type
- Biologics
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ID · 666d7e14-24e3-48fc-9f36-15dd35bf3705
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 949681
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.47(b)Review and approval of procedures
- 21 CFR 1271.75(d)Donors with risks not determined ineligible
- 21 CFR 1271.65(b)(2)Labeled re: biohazard, risks, test results
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
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Other FDA inspections of Conceptions Florida
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 21, 2025 | Not classified | Florida District Office | |
| March 14, 2023 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 26, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Conceptions Florida
- FDA Inspection 1270971 - 2025-05-21
- FDA Inspection 1200330 - 2023-03-14
- FDA Inspection 1099771 - 2019-06-26
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